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Canesten (6-Day Treatment Vaginal Tablets) is indicated for the treatment of vaginal thrush. It is inserted into the vagina for treatment at the site of infection. Only use this product if you have been previously diagnosed by your doctor as having vaginal thrush. The active substance in Canesten (6-Day Treatment Vaginal Tablets) is clotrimazole. Clotrimazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as vaginal thrush. How to use The insertion tube should be used to insert the vaginal tablet as deep as possible into the vagina, preferably before bedtime for six consecutive nights to ensure easy and comfortable treatment. Alternatively, two vaginal tablets can be inserted into the vagina before bedtime for three consecutive nights. You should wash your hands before removing the vaginal tablet and applicator from the package and again after you have finished using the applicator. 1. Remove the inlet tube from its packaging and pull the plunger and red lock out of the housing. 2. Place the vaginal disc into the open end of the housing with the curved edge facing down. Press the plunger and lock into the housing until you feel a click. 3. Once you feel a click, release the lock from the plunger and carefully insert the applicator tube into the vagina up to the decorative grip area. 4. Hold the applicator body by the textured grip area and carefully press the plunger all the way in until it stops, releasing the vaginal disc. 5. After use, disassemble all components for cleaning and wash thoroughly in hot (not boiling) soapy water, rinse for 30 seconds and wipe parts thoroughly. Keep it in a safe and clean place. When using it next, make sure the red lock is placed back in the plunger, and repeat the steps starting from step 2. After the last use, dispose of the insertion tube in a safe place, out of reach of children. Warnings and precautions Do not use Canesten (6-Day Treatment Vaginal Tablets): You are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten (6-Day Treatment Vaginal Tablets) (see Section 6. Further Information). During your period as it may be less effective. Before using Canesten (6-Day Treatment Vaginal Tablets), you should see your doctor if: You are unsure whether you have thrush or this is the first time you have had these symptoms. You have had more than two infections of thrush in the last six months. You or your partner have ever had a sexually transmitted disease. You are aged under 16 or over 60. You have ever had an allergic reaction to Canesten or any other vaginal antifungal products. You have any of the following symptoms: Irregular vaginal bleeding. Abnormal vaginal bleeding or a blood-stained discharge. Ulcers, blisters or sores of the vagina or vulva. Lower abdominal pain. Pain or difficulty in passing urine. Fever or chills. Feeling sick or vomiting. Diarrhoea. A foul smelling discharge from the vagina. This is because Canesten (6-Day Treatment Vaginal Tablets) may not be the right treatment for you. Special precautions: As with other vaginal tablets, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, you should use alternative precautions for at least five days after using this product. Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product. Avoid vaginal intercourse while you have thrush and during use of this product because your partner could become infected. Side Effects As with all medicines, some people may be allergic to the vaginal tablet. If you are allergic, a reaction will occur soon after you have used the medicine. If you experience an allergic reaction or the redness, burning, pain, itching or swelling get worse, stop using this product and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may include: Rash. Swallowing or breathing problems. Swelling of your lips, face, throat or tongue. Weakness, feeling dizzy or faint. Nausea. After you use the vaginal tablet you might experience: Itching, rash, swelling, redness, discomfort, burning, irritation, vaginal peeling, discharge or bleeding. Pain (eg. abdominal pain, vulvovaginal pain). Nausea. Storage Information Not to be stored above 30°C Drug Interactions Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor if you are taking tacrolimus or sirolimus (used to reduce the immune response to prevent rejection after an organ transplant). Simultaneous use of vaginally administered clotrimazole and oral tacrolimus (FK-506 immunosuppressant) can result in increased plasma tacrolimus and sirolimus levels. Patients should therefore, be monitored closely for symptoms of tacrolimus or sirolimus overdose, if necessary by determining the plasma concentration level of these drugs. Ingredients The active substance is: clotrimazole. The other ingredients are: calcium lactate pentahydrate, crospovidone, Silica colloidal anhydrous, lactose monohydrate, magnesium stearate, maize starch, Hypromellose 15 cP, cellulose microcrystalline, (s)-lactic acid
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